January 15, 2021
By Christina Sandefur
At a time when knowledge in healthcare has perhaps never been more important, it may shock you to learn that the federal government routinely censors the communication of valuable and truthful information that could help save people’s lives. Yet it does just that—and government promises to change this approach may be proving hollow.
The federal Food and Drug Administration (FDA) strictly limits how pharmaceutical companies—those with the most knowledge about treatments’ possible uses and side effects—can share information about the “off-label” use of their products. When a drug is prescribed for a different purpose, patient population, or dosage other than the FDA-approved indication, it is “off-label.” This practice is extremely common: Roughly 20 percent of all prescriptions written are for uses not approved by the FDA. If your child has ever been prescribed amoxicillin for an ear infection, for example, the prescription was off-label, since the FDA hasn’t approved this antibiotic for kids.
Not only does the FDA’s gag rule harm patients, it violates the constitutional right of free speech. Indeed, courts have said so for decades. Yet the FDA has routinely ignored and evaded these court rulings, despite the Agency’s own acknowledgement of widespread questions and concerns about its punishment of sharing information about off-label uses.
In 2018, the Agency inspired hope when it announced, under Dr. Scott Gottlieb’s leadership, its intention to clarify its policies with regard to off-label promotion and ensure they comport with the First Amendment. Unfortunately, this did not pan out: After Dr. Gottlieb departed the FDA, the Agency again changed course. Last September, the FDA proposed a rule change that not only fails to provide the needed clarity, but continues to flout the First Amendment.
Drug manufacturers have long expressed concern that simply knowing that their treatment is being prescribed off-label could trigger criminal penalties. These concerns are not unfounded: Howard Root, who had been the CEO of a lifesaving medical device company, faced fines, years in prison, and the destruction of the business he worked so hard to build—simply because one of his employees talked with a doctor about a legal use for a device. Root’s policy was that sales representatives could not discuss off-label uses of products, and the product in question made up only 0.1% of the company’s total revenues. Yet the FDA targeted Root and his company, even though the Agency made no claim that any patients were ever harmed. Root was eventually acquitted of all criminal charges by a jury, but only after a costly legal battle using time and money that could have been spent on research and development of breakthrough medical treatments. (You can learn more about Root’s story in the video below.)
With its latest proposed rule, the FDA seeks to allay healthcare industry fears. In the proposal’s executive summary, the Agency claims that it won’t use “mere knowledge” of an off-label use to establish a company’s intentions. But the actual rule allows the FDA to establish a manufacturer’s intent using a variety of factors, including “expressions,” “design,” or any “circumstances surrounding the distribution.” This doesn’t limit the FDA’s authority in a meaningful way, provides little guidance for drug manufacturers, and ignores decades of court decisions directing the FDA to respect free speech. At the end of the day, the new rule is functionally the same as the old rule: It empowers the government to punish people for speaking the truth.
It’s time to stop waiting on the FDA to fix this problem. Lawmakers should pass the Goldwater Institute’s Truth in Medicine Act to protect the sharing of truthful and non-misleading off-label information with doctors and payers. Until lawmakers act, manufacturers, doctors, and, above all, patients will suffer. As the Second Circuit observed, “in the fields of medicine and public health, ‘where information can save lives,’ it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”
Christina Sandefur is the Executive Vice President of the Goldwater Institute.